cone beam computed tomography for breast imaging

Conditions: Breast Cancer

Summary: the primary aim of this study is to investigate the use of cone beam computed tomography (cbct) for breast imaging in the diagnostic setting by providing a compelling body of evidence incorporating both non-contrast and contrast enhanced cbct in the study protocol. the goal is to accumulate a body of evidence to provide data to incorporate cbct into the diagnostic work-up of breast lesions.


Eligibility criteria:
inclusion criteria: group i: * are at least 40 years of age of any ethnicity * had a mammogram, read as bi-rads® 1 or 2 * will undergo study imaging no later than four weeks from date of mammogram. * is able to undergo informed consent. group ii: * are at least 40 years of age of any ethnicity * had a routine mammogram, read as bi-rads® 4 or 5 * are scheduled for breast biopsy * will undergo study imaging no later than four weeks from date of mammogram, prior to breast biopsy. * is able to undergo informed consent. group iii: * are at least 40 years of age of any ethnicity * had a routine mammogram, read as bi-rads® 4 or 5 * are scheduled for breast biopsy * will undergo study imaging no later than four weeks from date of mammogram, prior to breast biopsy. * is able to undergo informed consent. exclusion criteria: group i and group ii: * pregnancy * lactation * subjects with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker. * subjects who are unable to tolerate study constraints. * subjects who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to) * treatment for enlarged thymus gland as an infant * irradiation for benign breast conditions, including breast inflammation after giving birth * treatment for hodgkins disease * subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram. * subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to) * tuberculosis * severe scoliosis group iii: * pregnancy * lactation * subjects with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker. * subjects who are unable to tolerate study constraints. * subjects who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to) * treatment for enlarged thymus gland as an infant * irradiation for benign breast conditions, including breast inflammation after giving birth * treatment for hodgkins disease * subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram. * subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to) * tuberculosis * severe scoliosis * allergy or previous reaction to iodinated contrast material * history of renal dysfunction/kidney disease * long standing diabetes mellitus * multiple myeloma * dehydration * history of nephrotoxic medication use * hyperthyroidism * diabetic patients on metformin * pheochromocytoma * sickle cell disease

Keywords: breast cancer cone beam computed tomography